FDA bans red dye no. 3 in food

On January 16, 2025By Littum

The US Food and Drug Administration (FDA) will no longer allow red dye no. 3 is used in foods, beverages or ingested substances, such as cough syrup, the agency says announced Wednesday (January 15).

In its announcement, the FDA cited Delaney clause — part of the Federal Food, Drug and Cosmetic Act — as grounds for its decision. This clause requires the FDA to ban food and color additives found to cause cancer in humans or animals.

In this case, “or” is the operative word in this clause. In several studies, red dye no. 3 has been linked to cancer in male labs, but these carcinogenic effects have not been seen in other animals or in humans, the FDA noted.

Nevertheless, these rat studies forced the FDA to ban the additive from cosmetics and topical medications back in 1990, The Washington Post writes then. This decision followed a petition asking the FDA to investigate these specific uses of the dye. Ultimately, the agency also cited the Delaney Clause when it removed the additive from cosmetics and topical drugs, and now it has applied the same logic to foods and ingested drugs.

Related: What is brominated vegetable oil and why did the FDA ban it in food?

One of the rat studies involved feeding 70 male rats very high doses of red dye no. 3, corresponding to 4% of their diet over a lifetime. Fifteen of the rats developed tumors in the thyroid gland, one gland in the neck, but most of the tumors were not cancerous. Tumors did not appear in male rats fed lower doses of the dye or in female rats fed any dose. And when scientists performed the experiment on mice, rather than rats, they did not see tumors in males or females.

Later studies suggested that the tumors originated from a specific hormonal change triggered by the accumulation of red dye in male rats. But the hormonal mechanism is only relevant for rats, Posten reported.

In short, “the manner in which FD&C Red No. 3 causes cancer in male rats does not occur in humans,” the FDA emphasized in its announcement. What’s more, “relevant exposure levels to FD&C Red No. 3 for humans are typically much lower than those causing the effects shown in male rats.” The available documentation therefore suggests that ingestion of red no. 3 does not endanger people.

But “it doesn’t matter because the FDA mandate under the Delaney clause says if it shows cancer in animals or humans, they have to keep it out of the food supply,” Jennifer Pomeranzassociate professor of public health policy and management at New York University’s School of Global Public Health, told CNN.

As such, the FDA has banned the dye “as a matter of law,” its statement said.

Red dye no. 3, also known as erythrosin, gives the products a bright, cherry-red color. The FDA noted that the dye is found in some candies, cakes, cookies and frozen desserts, but that it is not as common as other food colours.

Specific brands of fruit cocktails, lollipops, beef sticks and candy corn are among the foods that contain the dye, according to a database compiled by the Environmental Working Group (EWG), a nonprofit consumer advocacy organization.

EWG, which has a sister lobbying organization called the EWG Action Fund, was a vocal proponent of the ban on red dye No. 3. In 2022, it and other organizations requested the FDA to reevaluate the additive and ask the agency to specifically consider the Delaney clause. (Historically, the EWG has drew some criticism to exaggerate the dangers of various chemicals in food and the environment.)

All American food manufacturers that use red dye no. 3, have until January 2027 to reformulate their products, while pharmaceutical manufacturers have until January 2028. Products imported into the country must also comply with the ban.

This article is for informational purposes only and is not intended to offer medical advice.